Substance Abuse, Pregnancy and Fetal Development: Early Start Intervention and Success

Transcription

1 Substance Abuse, Pregnancy and Fetal Development: Early Start Intervention and Success Nancy Goler MD Early Start Regional Medical Director Kaiser Permanente Northern California Region October 28, 2010

2 Agenda Usage in Pregnancy Opiates and Buprenorphine Early Start Intervention Appendix Slides

3 No Conflicts of Interest in Presentation No Disclosures

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5 Results from the 2008 National Survey on Drug Use and Health: National Findings U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Office of Applied Studies

6 2008: Past month illicit drug usage by age

7 Young Adults Age 18-25, past use 1 month

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9 Illicit Drug Usage in Pregnant Women 5.1% pregnant women used illicit drugs in the past month 9.8% non-pregnant Average rate of current illicit drug use was 5.1 percent no significantly change from (4.0 percent) and was similar to the rate observed in (4.6 percent). Among women aged 15 to 17 those who were pregnant had a higher rate of use than those who were not pregnant (21.6 vs percent)

10 2008 Alcohol by Gender, age 12 to 20

11 Pregnant Women (15-44 yo) Current alcohol usage: 10.6 % Binge drinking: 4.5% Heavy drinking: 0.8% Non-pregnant rates: 54.0, 24.2, and 5.5 percent, respectively). Note: The estimate for first-trimester binge drinking is higher than in , when it was 4.6 percent.

12 Prevalence of Fetal Alcohol Spectrum Disorders CDC studies have documented FAS prevalence rates ranging from 0.2 to 1.5/1,000 live births Classic medical education states FASD inclusive may be as high as 1 per 100 live births (40,000 infants per year in the US)

13 Fetal alcohol syndrome (FAS) Term first used in 1973 by Drs. Smith and Jones at the University of Washington One of the diagnoses used to describe birth defects caused by alcohol use while pregnant A medical diagnosis (760.71) in the International Classification of Diseases (ICD)

14 Umbrella term describing the range of effects that can occur in an individual whose mother drank alcohol during pregnancy May include physical, mental, behavioral, and/or learning disabilities with possible lifelong implications Not a diagnosis

15 All alcoholic beverages are harmful Binge drinking is especially harmful There is no proven safe amount of alcohol use during pregnancy

16 Permission to use photo on file.

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18 Cigarettes vs Cocaine in Pregnancy Perinatal Risks: Cigs Cocaine Increased SAB(>10cigs) Low Birth Weight Placental Abruption PPROM Preterm Delivery Placenta Previa Stillborn

19 Long Term Effects of Cigarettes: Respiratory Problems SIDS (increased RR ) Increased Behavioral Problems: GIRLS: Increase in substance abuse in adolescents BOYS: Increase in Oppositional Defiant Disorder (ODD)* *Wakschlag, LS et. al., Is Prenatal Smoking Associated with a Developmental Pattern of Conduct Problems in Young Boys?, Child and Adolescent Psychiatry, Vol 45(4), April 2006, pp

20 2008, Age 12 and older, new initiates

21 Past Year Initiates for Specific Illicit Drugs among Persons Aged 12 or Older:

22 Dependence on or Abuse of Specific Illicit Drugs in the Past Year among Persons Aged 12 or Older:

23 A Closer Look at Opiate Addiction in Pregnancy

24 Addiction in Pregnancy Opiate dependence (especially pills) is a significant and growing problem in the US Long term prescription opiate use in young (and pregnant) women warrants assessment for addiction to opiates Opiate addiction is a treatable condition

25 Opiates and Pregnancy Difficult to Screen If only using softer Signs/Symptoms Late entry to care Missed appointments Past Ob history History of children with problems or CPS History of other drug or alcohol problems NCal Early Start: Universal Screening with questionnaire and toxicology (with consent)

26 Opiates and Pregnancy Neonatal Outcomes Withdrawal Syndrome (NAS Neonatal Abstinence Syndrome) Prematurity Microcephaly Neurobehavioral Deficits SIDS

27 Opiates and Pregnancy Treatment Options for Addiction Methadone Programs Remains National Standard of Care Detoxification Prefer second trimester, generally inpatient Motivated patient Buprenorphine Consider continuing treatment if already on med No new starts yet (multicenter trials results pending) May require inpatient detox for new starts

28 Buprenorphine and Babies: Do they mix?

29 Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment

30 Breast Feeding While on Buprenorphine Treatment Buprenorphine passes into the breast milk of lactating women at a plasma-to-milk ratio of approximately 1. Very poor oral bioavailability Infant will be exposed to only 1/5 1/10 of the total amount of buprenorphine available.

31 Breast Feeding While on Buprenorphine Treatment The literature reports on approximately 40 to 50 women who were maintained on buprenorphine and who breastfed. (Johnson et al. 2003a; Lejeune et al. 2001; Loustauneau et al. 2002; Marquet et al.1997). Buprenorphine present in breast milk does not appear to suppress NAS. NAS has not been observed after the cessation of breastfeeding by women who were maintained on buprenorphine (Loustauneau et al. 2002).

32 Breast Feeding While on Buprenorphine Treatment Subutex and Suboxone package inserts state that breastfeeding is not advised It is the consensus of the panel that any effects of these medications on the breastfed infant would be minimal and that breastfeeding is not contraindicated. Given the limited literature in this subject area, physicians are advised to use their judgment in their recommendations.

33 A pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty. --Sir Winston Churchill

34 We believe that every woman deserves a non-punitive health care environment, such that she have access to services and support to have an alcohol, tobacco and drug free pregnancy, allowing the delivery of a healthy baby.

35 Early Start Innovation Place a licensed mental health provider in the department of Ob/Gyn Link Early Start appointments with routine prenatal care Universal screening Educate all women and providers

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37 2009 Early Start Data 38,216 questionnaires: 10,430 (27%) positive 8817 (84.5%) were assessed Negative assessment: 4513 (51.19%) Smoker Only: 1141 (12.94%) At Risk Diagnosis: 1800 (20.42%) Substance Abuse: 807 (9.15%) Chemical Dependency: 460 (5.22%)

38 Substance Abuse Treatment Linked with Prenatal Visits Improves Perinatal Outcomes: A New Standard Nancy Goler MD, Mary Anne Armstrong MA, Cosette J Taillac LCSW, and Veronica M Osejo BS Journal of Perinatology June 26, 2008

39 METHODS Study Members 49,985 female KP members Completed ES Prenatal Substance Abuse Screening Questionnaires 01/99-6/03 Urine toxicology screening test Live birth or Intrauterine Fetal Demise at a KP NCal Hospital

40 Definition of Study Groups: SAT (2073): Screened pos, assessed pos, follow-up SA (1203): Screened pos, assessed pos, but no follow-up S (156): Screened pos (including toxicology),no follow-up C (46,553) : Screened negative

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42 SELF-REPORTED SUBSTANCE USE ON SCREENING QUESTIONNAIRES % in group Characteristic SAT SA S Alcohol wkly/daily since preg Meth wkly/daily since preg THC wkly/daily since preg Alcohol wkly/daily before preg Meth wkly/daily before preg THC wkly/daily before preg Smoked cigarettes during preg

43 RATE OF DELIVERY BEFORE 37 WEEKS GESTATIONAL AGE BY STUDY GROUP 20.0% 17.4% 15.0% 10.0% 8.1% 9.7% 6.8% 5.0% 0.0% SAT SA S Controls

44 RATE OF NEONATAL ASSISTED VENTILATION BY STUDY GROUP 8.0% 6.9% 6.0% 4.2% 4.0% 3.2% 2.2% 2.0% 0.0% SAT SA S Controls

45 RATE OF LOW BIRTHWEIGHT (<2500 GRAMS) BY STUDY GROUP 20.0% 15.0% 12.4% 10.0% 6.5% 7.7% 4.7% 5.0% 0.0% SAT SA S Controls

46 RATE OF PLACENTAL ABRUPTION BY STUDY GROUP 8.0% 6.5% 6.0% 4.0% 2.0% 0.9% 1.1% 0.9% 0.0% SAT SA S Controls

47 RATE OF INTRAUTERINE FETAL DEMISE BY STUDY GROUP 7.1% 7.0% 6.0% 5.0% 4.0% 3.0% 2.0% 1.0% 0.5% 0.8% 0.6% 0.0% SAT SA S Controls

48 What could have been for the S group (156)? 15 more term babies 6 more babies breathing without a ventilator 9 more babies born at a normal birth weight 9 more women not experiencing an abruption 10 more babies alive

49 RESULTS of COST BENEFIT ANALYSIS Using 2000 Cost Data 30 % Estimated Simple Return on Investment Using 2004 Cost Data 53% Estimated Simple Return on Investment (Projections matched actuals in retrospect)

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51 For more information visit the Early Start Web Site

52 Appendix Slides FDA Drug Classification in Pregnancy Fetal Alcohol Spectrum Disorders Other drugs Caffeine Cigarettes/Cocaine Methamphetamine

53 United States FDA Pharmaceutical Pregnancy Categories Pregnancy Category A Pregnancy Category B Pregnancy Category C Pregnancy Category D Pregnancy Category X Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and wellcontrolled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

54 Alcohol and Pregnancy February 2005 We must prevent all injury and illness that is preventable in society, and alcohol-related birth defects are completely preventable. Dr. Richard Carmona U.S. Surgeon General

55 Prevalence: FAS/FASD CDC studies have documented FAS prevalence rates ranging from 0.2 to 1.5/1,000 live births Classic medical education states FASD inclusive may be as high as 1 per 100 live births (40,000 infants per year in the US)

56 Perinatal Effects of Alcohol Fetal alcohol syndrome (FAS) Term first used in 1973 by Drs. Smith and Jones at the University of Washington One of the diagnoses used to describe birth defects caused by alcohol use while pregnant A medical diagnosis (760.71) in the International Classification of Diseases (ICD)

57 Fetal Alcohol Spectrum Disorders (FASD) Umbrella term describing the range of effects that can occur in an individual whose mother drank alcohol during pregnancy May include physical, mental, behavioral, and/or learning disabilities with possible lifelong implications Not a diagnosis

58 FASD, continued All alcoholic beverages are harmful. Binge drinking is especially harmful. There is no proven safe amount of alcohol use during pregnancy.

59 FAS and the Brain Permission to use photo on file.

60 Terminology: Fetal Alcohol Spectrum Disorders (FASD) FAS (Fetal Alcohol Syndrome) PFAS (Partial Fetal Alcohol Syndrome) FAE (Fetal Alcohol Effects) ARND (Alcohol Related Neurodevelopmental Disorder) ARBD (Alcohol Related Birth Defects)

61 Diagnosis: FASD FASD is diagnosed based on the mother's history, the physical appearance of the baby, and development of the child. All must be present for pure FAS: Growth Problems (<10 th %) Facial Anomalies (thin upper lip, small eye openings, smooth area from lip to nare) CNS Damage (learning/behavioral problems)

62 Diagnosis: FASD Features Mental handicap Abnormal facial features Growth problems Birth defects Problems with the central nervous system Trouble remembering and/or learning Vision or hearing problems Behavior problems

63 Treatment: Multifaceted approach Raising public awareness regarding the dangers of alcohol use during pregnancy Educating and training health and social service professionals how to identify and intervene with women at risk for alcoholexposed pregnancies

64 Treatment: Multifaceted approach Developing effective intervention programs for children affected by prenatal alcohol exposure Promoting and supporting basic research to identify the etiology and mechanisms involved in FAS Improving the quality of life of affected persons and families

65 Improving the quality of life of affected persons and families There is no cure Effects are lessened with earlier intervention Referrals to medical specialists as well as behavioral specialists is often needed Family support and education

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67 Caffeine in Pregnancy Increases rates of SAB in 1 st Trimester Decreased ability to metabolize methylzanthines: cross placenta Neonates and newborns less tolerant No long term effects proven MDs recommend: Avoiding Caffeine (1/day)

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69 Cigarettes and Pregnancy Early Start 2005: 21.63% smoker only Perinatal Risks: Cigs Cocaine Increased SAB(>10cigs) Low Birth Weight Placental Abruption PPROM Preterm Delivery Placenta Previa Stillborn

70 Cigarettes and Pregnancy Long Term Effects: Respiratory Problems SIDS (increased RR ) Increased Behavioral Problems: GIRLS: Increase in substance abuse in adolescents BOYS: Increase in Oppositional Defiant Disorder (ODD)* Increase in Conduct Disorder Earlier on-set of significant delinquent behavior* *Wakschlag, LS et. al., Is Prenatal Smoking Associated with a Developmental Pattern of Conduct Problems in Young Boys?, Child and Adolescent Psychiatry, Vol 45(4), April 2006, pp

71 Cigarettes and Pregnancy COSTS: $2.0 billion (direct costs only) Smoking Cessation Programs Pharmacology (eg Bupropion class B) Nicotine Patch class D

72 Why follow women who say that they quit drinking at onset of pregnancy? Past alcohol use (especially in the month before pregnancy) is associated with greater alcohol use in pregnancy Heavy alcohol use before pregnancy is highly predictive of continued use in pregnancy

73 Why follow women who say that they quit drinking at onset of pregnancy? Binge drinking and frequent drinking rates in pregnancy (more than 5 drinks on one occasion or 7 or more drinks per week) have not declined in the past 10 years A number of women who binge drink in pregnancy are not alcoholic

74 My daughter tells three of her friends that it is okay to drink in pregnancy after the first trimester The friend tells three friends The friend tells three friends The friend tells three friends The number of women with incorrect information grows astronomically

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76 Methamphetamine and Pregnancy Epidemic in Hawaii and growing in the nation Speed, meth, chalk, ice crystal, and glass Is easily made in home labs Increased rates of smoking ( ice ): 1992: 12% 2002: 50% (HI 97%; CA 61%)

77 Methamphetamine and Pregnancy Perinatal Outcomes: Similar to effects of cocaine/amphetamines Placental Abruption Preterm Labor Blood Pressure Crisis Growth Retardation Stillborn Neonatal Withdrawal